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. 2024 Jan 31;17(2):192. doi: 10.3390/ph17020192

Table 1.

Registered nonprescription medicines containing plant raw materials announced on the official website of the Bulgarian Drug Agency.

№ Freely Chosen Name Medicinal Form and Quantity of the Active
Substance in a Dose Unit		 INN ATC Code Content Use among Pediatric Patients Plant-Based OTC Depending on the Active Substance Use of OTC in the Period of (in Accordance with the Age Differentiation among the Pediatric Population) Therapeutic
Indications
1. Bronchicum 100 mg
compressed
lozenges × 20; × 50		 Thyme fluid
extract		 R05CA00 Each tablet contains:
  • ✔

    Thymi herba extractum

    siccum equivalent to 100 mg Thymi herba extractum

    fluidum (1: 2–2.5)

 Over 4 years of age OTC1 Pre-school period Upper respiratory tract
2. Bronchicum Elixir S 5.0 g/2.5 g/100 g syrup—130 g Thymi herbae tincture//Grindelii herbae tincture/Quebrachi corticis tincture/Primulae radicis tincture/Pimpinellae radicis tincture R05CA10 100 mL of the syrup contains:
  • ✔

    Thymus vulgaris/zygis L., herba (1:2–2.5)

    (liquid extract from a blade of thymes)—5.0 g;

  • ✔

    Primula veris/elatior L., radix (1:2–2.5)—2.5 g.

 Over 4 years of age OTC2 Pre-school period Upper respiratory tract, cough
3. Broncholytin 5.75 mg/4.6 mg/5 ml syrup × 125 g Glaucine bromide/Basilici oil/Ephedrine hydrochloride R05FA02 B 5 mL of the syrup contains:
  • ✔

    Glaucine hydrobromide—5.75 mg;

  • ✔

    Eephedrine hydrochloride—4.6 mg.

 Over 3 years of age OTC2 Pre-school period Upper respiratory tract, cough
4. Bronchostop 59.5 mg pastilles × 20; × 40 Plant medicinal product R05CA 1 pastille contains:
59.5 mg Thymus vulg./Thymus zyg. L.) dry extract from blades (7–13:1)		 Over 12 years of age OTC1 School period
(middle school age)		 Upper respiratory tract, throat
5. Bronchostop 0.77 g/0.66 g/5 ml—syrup × 150 ml Plant medicinal product R05CA10 5 ml (approximately 5.7 g) of syrup contains:
  • ✔

    0.77 g Thymus vulg./Thymus zyg. dry extract from blades (1:2–2.5

  • ✔

    Althaea off., (liquid extract from roots (1:20)

 Over 4 years of age OTC2 Pre-school period Upper respiratory tract, cough
6. Bronchostop Duo 51.1 mg/4.5 mg pastilles × 10; × 20; × 30; × 40 Plant medicinal product R05CA 1 pastille contains:
  • ✔

    51.1 mg Thymus vulg./Thymus zyg.)

(7–13:1) water extract);
  • ✔

    4.5 Althaea off. (7–9:1)

 Over 6 years of age OTC2 Pre-school period Upper respiratory tract, cough
7. Bronchostop Sine 0.12 g/1.28 g/15 ml oral solution—100 ml; × 120 ml; × 150 ml; × 200 ml Plant medicinal product R05CA10 15 ml (=15.45 g) of the solution contains:
  • ✔

    0.12 g Thymus vulg.

    Thymus zyg. dry extract from blades (7–13:1).

  • ✔

    Althaea off., liquid extract from the roots (1:12–14)

 Over 2 years of age (not recommended for children under 2 years of age) OTC2 Early childhood Upper respiratory tract, cough
8. Bronchoton 4.6 mg/5.75 mg/5 ml syrup × 125 g Glaucine hydrochloride/Ephedrine hydrochloride/Basilici oil R05FA02 5 ml of syrup contains:
  • ✔

    Ephedrine hydrochloride—4.6 mg.

  • ✔

    Glaucine hydrobromide—5.75 mg.

 Over 3 years of age OTC2 Pre-school period Upper respiratory tract, cough
9. Carmolis Oral drops, solution/cutaneous solution/inhalation vapor, solution—20 ml; × 40 ml, × 80 ml; × 160 ml Anise oil/Clove oil/Citronella oil/Lavander oil/Lemon oil/Spirit of lemon balm/Menthol racemic/Nutmeg oil/Sage oil/Spiciae aetheroleum/Thyme oil Plant medicinal product 100 g Carmolis contains:
  • ✔

    Laevomentholum—1.72000 g.

  • ✔

    Thymi aetheroleum—0.00172 g;

  • ✔

    Anisi aetheroleum—0.01548 g;

  • ✔

    Cinn.cassiae aetheroleum—0.17716 g;

  • ✔

    Caryophylli floris aetheroleum—0.17716 g;

  • ✔

    Limonis aetheroleum—0.01118 g;

  • ✔

    Lavandulae aetheroleum—0.17716 g;

  • ✔

    Spicae aetheroleum—0.17716 g;

  • ✔

    Citronellae aetheroleum—0.01720 g;

  • ✔

    Salviae aetheroleum—0.03526 g;

  • ✔

    Myristicae aetheroleuml 0.07052 g

  • ✔

    Melissae spiritus/1:5/

 Not
recommended for children under 12 years of age		 OTC2 School period
(middle school age)		 Upper respiratory tract, cough
10. Cefabronchin 50 g/21 g/100 g oral drops, solution × 20 ml, × 50 ml, × 100 ml Plant medicinal product 100 g of drops contains:
  • ✔

    Thymi herba extractum

    fluidum (1:2–3) 50 g

    Extractum fluidum compositum (1:3–4) 21 g:

  • ✔

    Lichen islandicus;

  • ✔

    Saponariae rubrae radix;

  • ✔

    Pimpinellae radix;

  • ✔

    Eucalypti folium;

  • ✔

    Foeniculi amari fructus (1:1:1:1:1) et 1 pars

  • ✔

    Anisi stellati fructus

 Over 4 years of age OTC2 Pre-school period Upper respiratory tract, cough
11. Hedelix 0.8 g/100 ml syrup Hederae helicis folium
extractum
spissum		 R05CA12 100 ml of syrup contains:
0.8 g Hederae helicis folium extractum spissum with a proportion of the active substance and the extract (2.2–2.9: 1).		 Yes 0 + OTC1 Breastfeeding period Upper respiratory tract, cough
12. Hedespan 7 mg/ml syrup ×100 ml Plant medicinal product R05CA 0 1 ml contains:
7 mg extr. siccum Hedera helix L., folium 		Over 2 years of age OTC1 Early childhood Upper respiratory tract, cough
13. Herbion
iceland Moss		 6 mg/ml syrup × 150 ml Plant medicinal product 1 ml of syrup contains:
6 mg Cetraria islandica (L.) Ach, tallus (16–18:1)		 Yes (for children aged 4–6 after being diagnosed) OTC1 Pre-school period Upper respiratory tract, cough
14. Herbion Ivy 7 mg/ml syrup × 150 ml Plant medicinal product R05CA 12 1 ml of syrup contains:
7 mg Hederae helicis folium
extractum spirituosum siccum
(5–7.5:1)		 Over 2 years of age (contraindicated for children under 2 years of age) OTC1 Early childhood Upper respiratory tract, cough
15. Herbion Ivy lozengez × 8; × 16; × 24; × 32; × 40 Plant medicinal product R05CA 12 1 tablet for sucking contains: 35 mg Hedera helix L., folium extractum siccum (5–7.5:1) Over 6 years of age OTC1 Pre-school period Upper respiratory tract, cough
16. Hustagil Thyme Cough Syrup syrup × 150 ml Thyme fluid
extract		 R05CA 6 g (= 5 ml) contains medicinal substance:
480 mg Extr. Thymi fluidum (DAB) standardized over min. 0.03% Tymol		 Over 1 year of age OTC1 Early childhood Upper respiratory tract, cough
17. Ivitus 7 mg/ml oral solution— × 100 ml; × 150 ml; × 200 ml Expetorants R05CA 0 1 ml of solution contains:
Hedera helix L. folium (5–8:1)		 Over 2 years of age OTC1 Early childhood Upper respiratory tract, cough
18. Mucohelix syrup × 100 ml Hederae helicis
folii extractium siccum		 R05CA12 1 ml of syrup contains:
8.25 mg Hederae helicis folium extractum siccum 		Over 2 years of age OTC1 Early childhood Upper respiratory tract, cough
19. Mucoplant Spitzwegerich Hustensaft syrup 5 g/100 g × 100 ml; × 250 ml Plant medicinal product R05FB02 1 g (0.8 ml) of syrup contains: 50 mg Plantaginis lanceolatae folium extractum fluidum (Plantago lanceolata L.) (1:1) Over 2 years of age OTC1 Early childhood Upper respiratory tract, cough
20. Mucoplant Anisol Capsules 100 mg × 30 Anise oil/Anisi aetheroleum R05CA 1 capsule contains:
Anisi stellati aetheroleum—100 mg		 Over 12 years of age OTC1 School period
(middle school age)		 Upper respiratory tract, cough
21. Mucoplant Cough Syrup Ivy 154 mg/100 ml syrup × 100 ml; × 200 ml; × 250 ml Ivy leaf dry extract (Hedera helix L.) Extraction solvent: Ethanol R05C Each ml contains:1.54 mg Hedera helix L.
(DER 4–8:1)		 Over 2 years of age
(contraindicated for
children under 2 years of age owing to a risk of
deterioration of the
respective
symptoms)		 OTC1 Early childhood Upper respiratory tract, cough
22. Pinosol nasal drops, solution 10 ml Pine oil/Eucalyptus oil/Tocopherol acetate/Thymol/Guaizulene/Peppermint oil R01AX00 Medicines contain:
  • ✔

    Scots pine, oil—375.2 mg;

  • ✔

    Hot mint, oil—100 mg;

  • ✔

    Eucalyptus oil—50 mg;

  • ✔

    Alpha-tocopheryl acetate—170 mg;

  • ✔

    Thymol—3.2 mg;

  • ✔

    Guaiazulene—2.0 mg.

in 10 g solution. 1 mL = 25 gutt		 Over 6 years of age
for inhalation among children over 12 years of age		 OTC2 Pre-school period Upper respiratory tract, inflammation of the nasal and
nasopharyngeal mucous
membrane
23. Prospan 20 mg/ml oral drops, solution × 20 ml Hedera helix extract R05FB00 1 ml of solution contains:
  • ✔

    20 mg Hedera helix folium extractum siccum (5–7.5:1)

 Over 1 year of age OTC1 Early childhood Upper respiratory tract, cough
24. Prospan 65 mg eff. tablets × 10; × 20 Hedera helix
extract		 R05FB00 1 effervescent tablet contains: 65 mg Hedera helix folium
extractum siccum (5–7.5:1)		 Over 12 years of age (children over 6 years of age take ½ of an
effervescent
tablet 2 times a day)		 OTC1 Pre-school period Upper respiratory tract, cough
25. Prospan 26 mg lozenges × 10; × 20 Hedera helix
extract		 R05CA 1 tablet for sucking contains: 26 mg Hedera helix folium
extractum siccum (5–7.5): 1)		 Over 6 years of age OTC1 Pre-school period Upper respiratory tract, cough
26. Prospan 7 mg/ml syrup × 5 ml; × 100 ml; × 200 ml Hedera helix
extract		 R05FB00 1 ml of syrup contains:
7 mg Hedera helix folium
extractum siccum (5–7.5:1)		 Over 1 year of age. For children under 1 year of age it must be
prescribed by a doctor		 OTC1 Early childhood Upper respiratory tract, cough
27. Prospan Liquid 7 mg/ml oral liquid—5 ml × 21 Hedera helix extract R05FB00 1 ml of syrup contains:
7 mg Hedera helix folium
extractum siccum (5–7.5:1)		 Over 6 years of age OTC1 Pre-school period Upper respiratory tract, cough
28. Sinupret syrup × 50 ml, × 100 ml, × 200 ml, × 500 ml Plant medicinal product R05CA10 100 g of syrup contains:
extract (1:11) from:
  • ✔

    Gentianae radix;

  • ✔

    Primulae flos calycibus;

  • ✔

    Verbenae herba;

  • ✔

    Rumicis herba;

  • ✔

    Sambuci flos (1:3:3:3:3)

 Over 2 years of age OTC2 Early childhood Upper respiratory tract,
inflammation of the paranasal
sinuses
29. Sinupret coated tablets × 50; × 100; × 200; × 500 Rumicis herbae pulvis/Sambuci flos pulvis/Gentianae radix pulvis/Primulae flos pulvis/Verbenae herbae pulvis R05CA10 1 coated tablet contains:
  • ✔

    Gentianae radix pulv.—6 mg;

  • ✔

    Primulae flos cum calycibus pulv.—18 mg;

  • ✔

    Rumicis herba pulv.—18 mg;

  • ✔

    Sambuci flos pulv.—18 mg;

  • ✔

    Verbenae herba pulv.—18 mg.

 Over 6 years of age (not recommended for children under 6 years of age owing to the lack of sufficient evidence) OTC2 School period
(early school age)		 Upper respiratory tract, inflammation of the
paranasal sinuses
30. Sinupret Forte coated tablets × 20; × 50; × 100; × 500 Rumicis herbae pulvis/Sambuci flos pulvis/Gentianae radicis pulvis/Primulae flos pulvis/Verbenae herbae pulvis R05CA10 1 coated tablet contains:
  • ✔

    Gentianae radix pulv.—12 mg;

  • ✔

    Primulae flos cum calycibus pulv.—36 mg;

  • ✔

    Rumicis herba pulv.—36 mg;

  • ✔

    Sambuci flos pulv.—36 mg;

  • ✔

    Verbenae herba pulv.—36 mg

 Not
recommended for children under 12 years of age owing to the lack of
sufficient data		 OTC2 School period
(middle school age)		 Upper respiratory tract, inflammation of the
paranasal sinuses
31. Tavipec 150 mg gastro-resistant capsules, soft × 20; × 30 Spicae aetheroleum R05CA00 1 capsule contains: Spicae
aetheroleum—150 mg		 Over 12 years of age OTC1 School period
(middle school age)		 Upper respiratory tract, expectorant
32. Tuspan 7 mg/ml syrup × 120 ml Ivy leaf dry
extract		 R05CA12 1 ml of syrup contains:
7 mg extract from Hedera
helix L. (5–7.5:1)		 Over 2 years of age (not recommended for children under 2 years of age owing to their oversensitivity to the active
substance)		 OTC1 Early childhood Upper respiratory tract, expectorant
33. Tussavit 7.53 g/7.53 g/100 g syrup 125 g; 250 g Thymi folium extr./Plantaginis folium R05CA00 100 g of syrup contains:
  • ✔

    7.53 g Thymi vulgaris herba/Thymi zygis herba extractum fluidum (1:1);

  • ✔

    7.53 g Plantaginis lanceolatae folium extractum fluidum (1:1)

 Over 2 years of age (not recommended for children under 2 years of age owing to the content of alcohol) OTC2 Early childhood Upper respiratory tract, cough
34. Umckalor 20 mg film-coated tablets × 15; × 30 Plant medicinal product R05 1 coated tablet contains:
20 mg. dried liquid extract from Pelargonii sidoidi radix (1:8–10) (EPs 7630)		 Over 6 years of age OTC1 School period
(early school age)		 Respiratory tract, acute infections, bronchitis, sinusitis
35. Umckalor 8 g/10 g oral drops, solution × 20 ml; 50 ml; × 100 ml Pelargonii sidoidi radicis extractum liquidum R05 10 g (= 9.75 ml) contains
Pelargonii sidoidi radix extr. fliudum (1:8–10) (EPs 7630)		 Over 1 year of age OTC1 Early childhood Respiratory tract, acute infections, bronchitis, sinusitis